Knowde Enhanced TDS
Identification & Functionality
- Plastics & Elastomers Functions
- Technologies
- Product Families
Features & Benefits
- Materials Features
- Product Information
- More than half of New Chemical Entities (NCEs), which were developed recently, tend to show high crystallinity and poor solubility in water. Solid dispersion is a technique to improve the solubility and bioavailability of these NCEs. Hot-melt extrusion (HME) is one of the main methods to preparesolid dispersions.
- Enteric Polymers (e.g. AQOAT®, EUDRAGIT®, Kollicoat® etc.), which are widely used as an enteric coating agent, are useful carriers for solid dispersions and applicable for HME. However, these polymers are insoluble in water and users often have difficulties cleaning their extruder after processing.
Applications & Uses
- Markets
- Plastics & Elastomers Processing Methods
- User Guidelines for HME Cleaner Plus (GMP)
After your actual extrusion of solid dispersion, set your extruder (mixing zones) at more than 160°C (depending on scale size). HME Cleaner Plus (GMP) may adhere to the barrels when it is below 160°C. In cases of extrusion at higher temperature (200°C), keep the temperature for the first extrusion with HME Cleaner Plus (GMP) until substitution is completed. Then adjust the temperature (170°C) for additional cleaning extrusion. HME Cleaner Plus (GMP) starts to decompose over 200°C.
Regulatory & Compliance
- Regulatory and Quality Aspects
Shin-Etsu developed the HME Cleaner in 2012 as technical material. Based on Shin-Etsu’s formulation, BIOGRUND now offers this cleaner, produced in accordance with IPEC GMP guidelines and meeting all requirements of USP/NF, Ph.Eur. and JP. All ingredients have been used as pharmaceutical excipients including water-soluble cellulose ethers.